A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Official Title ICMJE

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Brief Summary

The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Detailed Description

Not Provided

Study Type ICMJE

Interventional

Study Phase

Phase 3

Study Design ICMJE

Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment

Condition ICMJE

Epilepsy, Partial

Intervention ICMJE

Drug: Levetiracetam (Keppra)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

238

Completion Date

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)

Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion Criteria:

Not be on a ketogenic diet (during the course of this study).

Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Gender

Both

Ages

up to 16 Years (Child)

Accepts Healthy Volunteers

Not Provided

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects